Study protocol for a randomized controlled trial testing the efficacy of Emotion Detectives In-Out: a blended version of the unified protocol for transdiagnostic treatment of emotional disorders in Portuguese children.
Anxiety disorders
Children
Coping cat
Emotion Detectives In-Out
Randomized controlled trial
Unified protocol for children
Journal
BMC psychology
ISSN: 2050-7283
Titre abrégé: BMC Psychol
Pays: England
ID NLM: 101627676
Informations de publication
Date de publication:
07 Feb 2024
07 Feb 2024
Historique:
received:
02
01
2024
accepted:
10
01
2024
medline:
9
2
2024
pubmed:
8
2
2024
entrez:
7
2
2024
Statut:
epublish
Résumé
Childhood emotional disorders (EDs; i.e., anxiety and depressive disorders) are currently a public health concern. Their high prevalence, long-term effects, and profound influence on the lives of children and families highlight the need to identify and treat these disorders as early and effectively as possible. This clinical trial will examine the efficacy of a blended version (i.e., combining face-to-face and online sessions into one treatment protocol) of the Unified Protocol for Children (the "Emotion Detectives In-Out" program). This program is a manualized cognitive-behavioral therapy for the transdiagnostic treatment of EDs in children aged 7 to 12 years that aims to reduce the intensity and frequency of strong and aversive emotional experiences by helping children learn how to confront those emotions and respond to them in more adaptive ways. This study is designed as a multicenter equivalence randomized controlled parallel-group two-arm trial comparing the Emotion Detectives In-Out program with an evidenced-based group intervention for children with anxiety disorders (the Coping Cat program). Participants will be children aged between 7 and 12 years with an anxiety disorder or with clinically significant anxiety symptoms as well as one of their parents or a legal representative. A minimum sample size of 138 children (69 per group) is needed to test whether the efficacy of the proposed intervention is equivalent to that of the well-established Coping Cat intervention. We expect Emotion Detectives In-Out to be a feasible and efficacious alternative intervention for treating children's EDs by allowing for a greater increase in children's access to care. A blended format is expected to overcome common barriers to treatment (e.g., parents´ lack of time to attend regular sessions) and make the intervention more accessible to families. The clinical trial is registered at ClinicalTrials.gov (Identifier: NCT05747131, date assigned February 28, 2023).
Sections du résumé
BACKGROUND
BACKGROUND
Childhood emotional disorders (EDs; i.e., anxiety and depressive disorders) are currently a public health concern. Their high prevalence, long-term effects, and profound influence on the lives of children and families highlight the need to identify and treat these disorders as early and effectively as possible. This clinical trial will examine the efficacy of a blended version (i.e., combining face-to-face and online sessions into one treatment protocol) of the Unified Protocol for Children (the "Emotion Detectives In-Out" program). This program is a manualized cognitive-behavioral therapy for the transdiagnostic treatment of EDs in children aged 7 to 12 years that aims to reduce the intensity and frequency of strong and aversive emotional experiences by helping children learn how to confront those emotions and respond to them in more adaptive ways.
METHODS
METHODS
This study is designed as a multicenter equivalence randomized controlled parallel-group two-arm trial comparing the Emotion Detectives In-Out program with an evidenced-based group intervention for children with anxiety disorders (the Coping Cat program). Participants will be children aged between 7 and 12 years with an anxiety disorder or with clinically significant anxiety symptoms as well as one of their parents or a legal representative. A minimum sample size of 138 children (69 per group) is needed to test whether the efficacy of the proposed intervention is equivalent to that of the well-established Coping Cat intervention.
DISCUSSION
CONCLUSIONS
We expect Emotion Detectives In-Out to be a feasible and efficacious alternative intervention for treating children's EDs by allowing for a greater increase in children's access to care. A blended format is expected to overcome common barriers to treatment (e.g., parents´ lack of time to attend regular sessions) and make the intervention more accessible to families.
TRIAL REGISTRATION
BACKGROUND
The clinical trial is registered at ClinicalTrials.gov (Identifier: NCT05747131, date assigned February 28, 2023).
Identifiants
pubmed: 38326847
doi: 10.1186/s40359-024-01532-z
pii: 10.1186/s40359-024-01532-z
pmc: PMC10851582
doi:
Banques de données
ClinicalTrials.gov
['NCT05747131']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
63Subventions
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Organisme : Fundação para a Ciência e a Tecnologia
ID : https://doi.org/10.54499/PTDC/PSI-GER/0689/2020
Informations de copyright
© 2024. The Author(s).
Références
J Anxiety Disord. 2013 Oct;27(7):711-9
pubmed: 24135256
Evid Based Ment Health. 2022 Feb;25(1):36-44
pubmed: 34281985
Glob Ment Health (Camb). 2016 Jul 14;3:e22
pubmed: 28596890
J Consult Clin Psychol. 1994 Feb;62(1):100-10
pubmed: 8034812
Psychol Assess. 2011 Sep;23(3):606-14
pubmed: 21480722
J Consult Clin Psychol. 2010 Oct;78(5):737-45
pubmed: 20873909
J Anxiety Disord. 2015 Jan;29:83-92
pubmed: 25527900
Compr Psychiatry. 2014 Nov;55(8):1920-7
pubmed: 25113056
Soc Psychiatry Psychiatr Epidemiol. 1997 May;32(4):230-5
pubmed: 9184469
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
JAMA Pediatr. 2021 Nov 1;175(11):1142-1150
pubmed: 34369987
J Med Internet Res. 2018 Dec 18;20(12):e11007
pubmed: 30563817
J Consult Clin Psychol. 1991 Feb;59(1):12-9
pubmed: 2002127
Behav Ther. 2013 Jun;44(2):325-37
pubmed: 23611081
Scand J Child Adolesc Psychiatr Psychol. 2021 Apr 23;9:64-72
pubmed: 33928055
Eur Child Adolesc Psychiatry. 2017 Jun;26(6):623-647
pubmed: 28054223
Clin Child Fam Psychol Rev. 2019 Jun;22(2):147-171
pubmed: 30229343
J Cogn Dev. 2010;11(2):121-136
pubmed: 21743795
J Consult Clin Psychol. 2005 Jun;73(3):498-505
pubmed: 15982147
Soc Psychol Personal Sci. 2017 May;8(4):355-362
pubmed: 28736600
Behav Res Ther. 2000 Aug;38(8):835-55
pubmed: 10937431
J Consult Clin Psychol. 1986 Aug;54(4):528-36
pubmed: 3745607
J Clin Child Adolesc Psychol. 2002 Dec;31(4):540-7
pubmed: 12402572
J Pediatr. 2019 Mar;206:256-267.e3
pubmed: 30322701
Assessment. 2023 Jun;30(4):1065-1079
pubmed: 35272501
J Med Internet Res. 2018 Feb 19;20(2):e59
pubmed: 29459357
J Med Internet Res. 2018 Jul 04;20(7):e234
pubmed: 29973338
JMIR Ment Health. 2016 Feb 09;3(1):e9
pubmed: 26860537
Psychol Assess. 2016 Aug;28(8):898-907
pubmed: 26460898
Internet Interv. 2023 Nov 02;34:100687
pubmed: 38023966
Psychiatry (Edgmont). 2007 Jul;4(7):28-37
pubmed: 20526405
Qual Life Res. 2010 Dec;19(10):1487-500
pubmed: 20668950
J Psychiatr Res. 2018 Sep;104:211-216
pubmed: 30103069
Psychiatr Serv. 2014 Jan 1;65(1):24-32
pubmed: 24081188
J Med Internet Res. 2017 Sep 15;19(9):e306
pubmed: 28916506
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
NPJ Digit Med. 2019 Feb 11;2:6
pubmed: 31304356
Child Psychiatry Hum Dev. 2016 Feb;47(1):113-23
pubmed: 25869734
Clin Child Fam Psychol Rev. 2017 Jun;20(2):185-200
pubmed: 27787701
Int J Environ Res Public Health. 2022 Feb 04;19(3):
pubmed: 35162806
BMC Psychiatry. 2015 Dec 12;15:311
pubmed: 26651478
J Abnorm Child Psychol. 2008 May;36(4):487-97
pubmed: 18214667
Health Qual Life Outcomes. 2015 Apr 25;13:50
pubmed: 25908249
Curr Opin Psychiatry. 2015 Jul;28(4):330-5
pubmed: 26001925
Behav Modif. 2019 May;43(3):330-360
pubmed: 29374963
N Engl J Med. 2008 Dec 25;359(26):2753-66
pubmed: 18974308
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Clin Child Fam Psychol Rev. 2002 Mar;5(1):57-83
pubmed: 11993545
PLoS One. 2015 Mar 18;10(3):e0119895
pubmed: 25786025
Eur J Epidemiol. 2020 Mar;35(3):205-222
pubmed: 32140937
JAMA. 2006 Mar 8;295(10):1152-60
pubmed: 16522836
J Child Psychol Psychiatry. 2022 May;63(5):527-534
pubmed: 34318492
J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):731-736
pubmed: 17513985